Decision on emergency use listing of Covaxin likely in 4-6 weeks: WHO | India News


NEW DELHI: The World Health Organisation (WHO) is likely to take decision on Emergency use Listing (EUL) of Bharat Biotech’s Covid-19 vaccine Covaxin in the next four to six weeks.
Addressing a webinar on Friday, Soumya Swaminathan, the global health body’s chief scientist has said that WHO is reviewing Covaxin as its manufacturer Bharat Biotech is now uploading its entire data on the health body’s portal, news agency PTI reported.
“There is a process to be followed for EUL and pre-qualification of vaccines under which a company has to complete phase 3 trials and submit the whole data to the regulatory department of WHO which is examined by an expert advisory group,” Swaminathan said.
“The completeness of the data, which includes safety and efficacy and also the manufacturing quality, standard is provided. So, I expect that Bharat Biotech has already submitted data and in four to six weeks there will be a decision on its inclusion,” she added.
The chief scientist further said that at present, there are 105 candidate vaccines in clinical evaluation out of which 27 are in phase three or four.
Speaking about Delta variant of the coronavirus, Swaminathan said two complete doses are required for protection adding that it is very transmissible.
Last month, Suchitra Ella, joint managing director of Bharat Biotech said the EUL of Covaxin by WHO is not a long drawn process as majority of the vaccine makers’ facilities have been audited by the global health body.
With 10 scientific publications in 12 months, Covaxin is one of the very few vaccines to have extensive data published in globally renowned peer-reviewed journals, she said.
At present, the WHO has approved vaccines by Pfizer/BioNTech, Astrazeneca-SK Bio/Serum Institute of India, AstraZeneca EU, Janssen, Moderna and Sinopharm for emergency use.
(With PTI inputs)
Watch Covaxin might get WHO nod for ’emergency use listing’ in first week of August





Source link

Leave a Reply

Your email address will not be published. Required fields are marked *